IPCA Laboratories gets OAI status from USFDA for Piparia unit

26 Nov 2019 Evaluate

Ipca Laboratories has received communication from United States Food & Drug Administration (USFDA) classifying that the inspection of its Piparia (Silvassa) formulations manufacturing unit as ‘Official Action Indicated (OAI)’ and that this facility is considered to be in an unacceptable state of compliance with regards to current good manufacturing practice (CGMP). Since this manufacturing facility is already under USFDA import alert and presently not doing any US business.

Earlier, USFDA has inspected Piparia (Silvassa) formulations manufacturing unit from August 19, 2019 to August 23, 2019 which resulted into 3 observations under USFDA Form 483.

Ipca Laboratories is engaged in manufacturing of active pharmaceutical ingredients and formulations. It operates in 110 countries and its export accounts for 50% of the company’s income. Worldwide the company is one of the largest suppliers of APIs and intermediates. The company holds leadership position in Anti-malarial and Rheumatoid Arthritis area.

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